RTSM / IRT · Clinical Ops + Statistician + CRC
↔ sharedCuRE Cascade
Randomization + trial supply orchestration on the OMOP substrate — IRT without the IRT vendor.
What it does
Randomization + trial supply orchestration on the OMOP substrate — IRT without the IRT vendor. Algorithm core is built in-house and validated to randomizeR / carat as statistical-equivalence oracles.
Key capabilities
- Randomization engine (block / stratified / minimization / biased-coin)
- Trial supply: inventory, shipments, expiry, resupply rules
- Code break / emergency unblinding
- Amendments as config diffs
- Lot-recall workflow: cross-study quarantine, dispensation block, e-signed recall notices
- IMP lot/batch lifecycle, EU/UK QP-release gating (Annex 16), and cold-chain temperature-excursion disposition
- Predictive supply simulation (Monte-Carlo demand + overage)
- Accountability-ledger anomaly detection
- Expiry-extension & re-labeling workflow
- Bidirectional EDC/eCOA interop connectors
What sets it apart
- Algorithm core is built in-house and validated to randomizeR / carat as statistical-equivalence oracles.
- Predictive supply simulation forecasts demand and optimizes overage from the enrollment RWD Cascade owns — RTSM's flagship differentiator.
- DTP shipping, dose escalation, sponsor-list import, blinding firewalls, pooling, and EDC/eCOA interop complete the RTSM table stakes.
- Randomization + dispensation events write to the platform OMOP store — no separate IRT silo.
- Control-plane for depot ops; physical last-mile via partners (Almac / Marken), not reinvented.
Build a randomization schedule
Pick an algorithm, configure the arms and stratification, and generate an allocation sequence on synthetic subjects. Change the seed to see reproducibility; change the algorithm to see how each one trades off balance, predictability, and covariate control.
Arms shuffled within fixed-size blocks — balance is guaranteed at every block boundary.
Same seed → identical schedule, every time. That reproducibility is what makes a randomization list auditable.
Arm balance · 48 subjects
The vertical marker on each bar is the target allocation.
Allocation sequence
Why this is more than a toy
The schedule above is produced by a vendored, byte-for-byte copy of CuRE Cascade's randomization core — including its R-compatible MT19937 PRNG. In the product, that engine is validated for statistical equivalence against the randomizeR and carat packages as oracles, and every draw is written to the platform's OMOP store inside a 21 CFR Part 11 audit envelope. Here it runs entirely client-side on synthetic subjects.
See CuRE Cascade in action
Every research ecosystem is unique. Let's discuss how CuRE can be configured for your needs.